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Behavioral Intervention
Digital Cognitive Behavioral Therapy for Chronic Insomnia (SLEEP-I Trial)
N/A
Waitlist Available
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age between 22-64 years
English-speaking (both reading and writing in English required)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 61 weeks post-randomization
Awards & highlights
SLEEP-I Trial Summary
This trial will test a new digital device that delivers Cognitive Behavioral Therapy for Insomnia using a data-sharing platform. 100 patients will be monitored for 61 weeks.
Who is the study for?
This trial is for English-speaking adults aged 22-64 with chronic insomnia who can consent, use a smartphone with apps, and have primary care at YNHH or Mayo Clinic. It's not for pregnant individuals, shift workers with irregular sleep patterns, those without reliable internet and smartphone access, or people with certain psychiatric disorders or untreated sleep conditions.Check my eligibility
What is being tested?
The study tests a mobile app delivering Cognitive Behavioral Therapy for Insomnia (CBT-I), linked to Fitbit data over 61 weeks. The aim is to see how well the app works in real-world settings when patients share their data through a new platform.See study design
What are the potential side effects?
Since this intervention involves digital therapy using an app and Fitbit device rather than medication, typical drug side effects are not expected. However, users may experience discomfort from wearing the device or stress if technical issues arise.
SLEEP-I Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 64 years old.
Select...
I can read and write in English.
Select...
I have been diagnosed with chronic insomnia.
SLEEP-I Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to 61 weeks post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 61 weeks post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Secondary outcome measures
Change Quality of Life
Anxiety
Change in Daytime Sleepiness
+8 moreSLEEP-I Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: PEAR-003b PDT InterventionExperimental Treatment3 Interventions
Participants will receive the PEAR-003b digital therapeutic, a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Group II: Control ArmPlacebo Group2 Interventions
Participants will receive a Fitbit, and materials on sleep hygiene and healthy sleep tips. Using the Hugo platform, patient-generated engagement data, healthcare utilization, and patient activity/clinical outcomes for patients with insomnia will also be collected.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PEAR-003b PDT Intervention
2021
N/A
~100
Fitbit
2021
N/A
~3560
Sleep education materials
2021
N/A
~100
Find a Location
Who is running the clinical trial?
Mayo ClinicOTHER
3,205 Previous Clinical Trials
3,766,684 Total Patients Enrolled
Pear Therapeutics, Inc.Industry Sponsor
5 Previous Clinical Trials
1,817 Total Patients Enrolled
National Evaluation System for health Technology Coordinating Center (NESTcc)UNKNOWN
3 Previous Clinical Trials
8,118 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried cognitive behavioral therapy for insomnia without success.I am willing to use the PDT, Hugo platform, and devices like Fitbit.I have been diagnosed with chronic insomnia.I am in a non-medication program for insomnia but may be taking sleep meds.I have not been diagnosed with psychosis, schizophrenia, bipolar disorder, or any condition that makes sleep restriction unsafe.I can read and write in English.I am between 22 and 64 years old.I have a sleep condition like sleep apnea that hasn't been treated.I am willing and able to consent to participate in the study.
Research Study Groups:
This trial has the following groups:- Group 1: PEAR-003b PDT Intervention
- Group 2: Control Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chronic Insomnia Patient Testimony for trial: Trial Name: NCT04909229 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this investigation accept participants younger than 55 years old?
"This research initiative is searching for participants that are between the ages of 22 and 64."
Answered by AI
Is there still an opportunity for participants to join this experiment?
"Affirmative. Clinicaltrials.gov has evidence that confirms this clinical trial began recruiting patients on December 20th 2021 and is still ongoing; the most recent update was made September 14th 2022. A total of 100 individuals are needed for participation across two medical centres."
Answered by AI
Who is eligible to partake in this research endeavor?
"This sleep-based study is seeking 100 participants between the ages of 22 and 64 who suffer from chronic insomnia. Those interested must meet a few criteria: they need to be able to give consent, use certain digital tools, have an email account, as well as access to a smartphone capable of downloading relevant applications."
Answered by AI
What is the scope of participation in this experiment?
"Affirmative, the data posted on clinicaltrials.gov attests to this trial's active recruitment phase, which began in December 2021 and was most recently revised on September 14th 2022. Aspiring participants should note that a total of 100 enrollees are being sought across two distinct locations."
Answered by AI
Who else is applying?
What state do they live in?
New Hampshire
Connecticut
What site did they apply to?
Yale-New Haven Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
Would like to solve my sleep issues. I saw the ad on facebook and decided to try it.
PatientReceived 1 prior treatment
I have been diagnosed with idiopathic insomnia for over 30 years. I have been on numerous medications, tried Cognitive Behavior Therapy and hypnosis. When I go to sleep, wake up every 1.5 to 2 hours all night. I had 2 sleep studies years ago that ruled out sleep apnea, but showed I don't go into REM sleep. Nothing has helped. I am as exhausted when I wake up as I am when I go to sleep.
PatientReceived 2+ prior treatments
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